Validation of Aseptic Gowning Procedures

Standard Operating Procedure
Title: Validation of Aseptic Gowning Procedures

Document Owner
Micro Laboratory Manager
Affected Parties
All Validation and Microbiology Labora tory colleagues
Purpose
Aseptic gowning is the ability to complete the gowning procedure without compromising the sterility of the
garment. This SOP outlines the sterile gowning validation procedure as required for the final sign off for the
initial steri
le training and the revalidation of currently trained Operators , Fitters, Electricians and Cleaners
and all organization staff who are authorised to enter Sterile areas .
Responsibilities
i Each Functional Area Manager is responsible for ensuring that all st aff who are required to enter Sterile
areas have successfully demonstrated their gowning competency through passing their gowning
validation.
i The Microbiology Laboratory staffs are responsible for carrying out the review of the gowning
competency and asses
sing the results.
i
The Training department is responsible for recording and storing (filing) the results in the individuals
training files and keeping the individuals /teams updated with this information .
i The Training Department is responsible for the scheduling and booking of all sterile training and
retraining sessions.
Definition
cfu Colony Forming Unit representing one micro -organism
Aseptic Free from contamination
Contact plates Sterile dish of microbiological media used to monitor surfaces such as st erile gowns
Related Documents
MICLAB 005 Entry Procedure of Sterile Filling Area
Form 655 Validation Record For Sterile Gowning Procedure
EHS Statement
i Safety glasses and gloves
must be worn when using IPA .
i
Personnel who are ill , e.g. with a cold, flu
symptoms, stomach disorder, open lesions, any type of skin
disorder such as sunburn must check with their Process Manager / Microlab Department before they
can enter the sterile areas.
Department Micro Laboratory Document no
MICLAB 010
Prepared by:
Date:
Supersedes:
Checked by:
Date:
Date Issued:
Approved by:
Date:
Review Date:
Standard Operating Procedure
Title: Validation of Aseptic Gowning Procedures
______________________________________________________________________________________
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3. Areas of the gown to be monitored at validation
i
Gloves (without the addition of Hexifoam ).
i
Gown sleeves (at cuff)
i
Gown chest (
at zipper top)
i
Hood (near forehead)
i
Hood (side or back)
i
Gown (at top of overshoes at knee)
i
Overshoes (at top of foot)
3.1.
At the time of the Validation session , the Microbiology Laboratory observer will label all
plates with the candidate
s name, area monitore
d and the date.
3.2. The plates will then be brought to the Microbiology Laboratory together with
Form 655 for
incubation at 32p
C for 48 hours. The plates will be then transferred into the 25
C for 72
hours. After the incubation the results will be read and rec
orded in the registrar book. The
form is to be signed by the Microbiology Laboratory observer and photocopied and the copy
sent to Training Dept . for filing in the Operator
s Training File. The original document will be
kept in the Microbiology Laboratory
Validated Sterile Operators folder .
The individual should not enter the sterile area until a gowning validation has been
successfully completed.
3.3.
Individuals will be notified with their results and copied to their Process Manager . Successful
trainee shoul
d be grant access to the sterile areas.
4. Method of Re-Validation
4.1. Annual re-validation is required for all validated personnel and will consist of the sterile re -
training sessions followed by the aseptic gowning procedure validation . For personnel being
retrained a Re-validation needs to be completed within
1 month.
4.2. The revalidation
procedure is the same as the procedure outlined in Section 3
5. Acceptance Criteria
5.1.
The acceptance criteria are less than or equal to 1 cfu per plate for finger dabs and no more
than a total of 3 cfus / set of 6 contact plates or per single contact plate .
5.2.
If the acceptance criteria are not met then a second validation is permitted . In this event
notification will be sent to the Process Manager and the individual concerned .
6. Actions in the Event of a Failure
6.1. In the event of a failure the Microbiology Laboratory will inform the relevant individual
concerned and their Process Manager to ensure follow up steps are appropriate . This may
include counselling or re -training if deemed neces
sary.
6.2.
The objective of the counselling session is to :
6.2.1.
Highlight the results to the operator .
6.2.2.
Discuss potential causes; provide advice to help prevent recurrence.
6.2.3.
Outline the remedial action , which will be taken .
7.
Remedial Actions Initial Validation (After F
ull Sterile Training)
7.1. In the event of a failure of the initial validation a re -
validation is permitted .
Form 655
Issue date:
Validation Record For Sterile Gowning Procedure
(Ref. MICLAB 010)
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Participant
Date
Position
Validation
Attempt
Team/Work Area
Reason for Validation Please
Tick
Reports to New Sterile Operator
Annual Re-validation
Three Months
Comments
Other
(Please Specify)
GOWNING PROCEDURE CHECKLIST
CONFORMS (Y/N) / COMMENTS
1. Dirty
side procedures, hands and nails free
of excess dirt, fresh band aids on cuts.
2.
Undergarments and hairnets, correct use.
3. Putting on Sterile socks while crossing barrier
between dirty and clean
sides.
4. Putting on slip -
on safety shoes.
5.
1st wash -
hands & forearms including area
between fingers. Contact time of Biocide
solution
at least 60 sec.
6. Nailbrush scrub with Biocide solution
-
Top surface of nails, under fingernails rinsing
procedure.
7.
Drying with sterile wipe (picked up from the
top of the pile )
forearms, hands.
8. Putting on Hood
technique, not touching
external surface, hair net coverage.
9. Putting on Face mask
technique, position.
10.
2nd wash - h
ands & forearms including area
between fingers. Contact time of Biocide
solution
at least 60 sec.
11.
Drying with sterile wipe (picked up from the
top of the pile ) -
forearms, hands
12. Putting on Overalls uniform not touching
floor, not touching external su
rface, covering
hood flap.
13. Putting on Overshoes not touching external
surface, foot straps and clips.
14. Putting on Gloves
technique, not touching
external surfaces with bare hands.
15. Pulling up Overshoes
leg straps and clips.
Validated Microbiolo gy Print Sign
Technician